Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

Alexandra Cristina Senegaglia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ischemic Cardiomyopathy

Treatments: Procedure: MSCs injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01913886

MSC_Isquemica

Details and patient eligibility

About

This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.

Full description

Ischemic heart disease is a major public health problem in the industrialized and developing world. Current research is focusing on the development of cell-based therapies using stem cells to treat heart failure. Mesenchymal stem cells (MSCs) can differentiate into endothelial cells and participate in the development of new blood vessels in the heart damaged. Therefore, MSCs has shown promise for heart repair. The investigators study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic coronary artery disease
• NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with.
• Ejection fraction between 35% and 55%.
• Stable medical therapy for at least one month
• Patients clinically treated with coronary angioplasty with or without intraluminal stent.
• Patients with surgical revascularization and without the possibility of new invasive intervention.

Exclusion criteria

• Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
• An active uncontrolled infection.
• Pregnancy.
• Mental disability.
• Terminal illnesses.
• Valvular heart disease, congenital heart disease or other causes of cardiomyopathy than ischemic.
• Life perspective by other diseases under 1 year.
• History of severe arrhythmias
• Renal dysfunction or against medication
• Inability to perform cardiac catheterization.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

MSCs injection

Experimental group

Description:

Injection of autologous bone marrow-derived mesenchymal cells

Treatment:

Procedure: MSCs injection